Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- To ensure eQMS, study documentation and data (paper and electronic) is archived and retained in accordance with appropriate regulations
- To ensure issues related to documentation control and archiving are dealt with or escalated as required
- To comply & adhere to GCP guidelines and regulations as required of this role
- To ensure data quality and data integrity of all records prior to archiving
- To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards
- To ensure data is stored safe in a manner that minimizes deterioration and prevent loss at all times
Main tasks and responsibilities will include:
- Accountable for the management and operation of the site archiving processes
- Responsibility for the efficient maintenance of the temporary document storage facility
- Production and maintenance of the site Electronic Archiving system
- To act as site Electronic Archivist - Responsibility for the care and management of electronically archived material produced as a result of activities at Quotient Sciences
- Ensures records are controlled, protected, backed-up (electronic) and maintained to ensure their validity and integrity throughout their lifecycle (paper or electronic)
- Advising on information organization and classification (paper or electronic)
- Owner of retention schedule and ensures ongoing maintenance
- Presenting on documentation control and archiving process compliance at QA and cross functional compliance meetings, ensuring escalation issues of non-compliance in a timely manner
- Ensures all archivist are competent and trained
- Ensuring that records submitted for archiving correspond to the description (paper or electronic)
- Ensuring that the orderly storage and retrieval of records is facilitated/indexed (paper or electronic)
- Ensures the readability, legibility, availability, traceability and preservation of records/data within the paper or electronic archive
- Controls and provides authorized access to the paper/electronic archive and archived records
- Work with IT when support for general queries, pre-archival checks and data destruction is needed (electronic documents)
- Work with applicable departments and responsible person to prepare the study specific documents and trial related sources for archiving.
- Responsible for properly track documents and sources in or out of the archiving area upon request
- Prepare sources and data for audits and inspections
- Prepare all studies to be properly archived as required per agreements and procedures (documents and sources)
- Ensure proper transfer and tracking of on-site archived boxes and data to long term storage supplier
- Ensure that records are properly dispose once they have been retained for their required lifetime in accordance with customer agreement and applicable regulatory requirements
- Perform other duties as required
- Include Cross Training with GCP QA Associate
- Ensure read and understood of applicable procedures and policy in a timely manner
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Educated to at least completion of High School
- Competent in the use of Microsoft Office packages including Word, Excel, and other systems like eQMS, eQDocs and eDCS
- Experience and knowledge of documentation, archiving and training processes within a GCP regulated environment and QA department
- Preferable experience of working in a clinical research environment or equivalent experience in another role
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.